Note: Descriptions are shown in the official language in which they were submitted.
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Device for the Application of a Transcutaneous
Electrical Stimulation Stimulus
The invention relates to a device for the application of a transcutaneous
electric
stimulation stimulus onto the surface of a section of the human ear, which
comprises a number of electrodes, which are arranged at or in an electrode
carrier,
wherein the device comprises a controlling device which controls or closed-
loop
controls the creation of a potential difference between the electrodes,
wherein the
device comprises signal means which display or indicate the resistance which
exists
between the electrodes at generated potential difference when the device is
arranged at or in the ear, wherein the signal means comprise at least one
signal
element which is switched in dependence of the measured resistance.
It is generally known to take influence on the neurophysiological and
neuroelectrical quality through invasive and non-invasive stimulation of the
nerves
and thereby on the function of the simulated nerves. Hereby different
conditions of
sickness can be treated. Numerous devices exist both for the invasive and the
non-
invasive stimulation.
The present invention is basing upon the method of the transcutaneous
electrical
stimulation of the nerves. At this method pulse currents of different current
forms,
amplitudes, pulse durations and frequencies are administered through the skin
on
different nerves and change their status parameter in an advantageous way.
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A device of the kind mentioned above is disclosed in US 5 514 175 A and US
2009/0082831 Al. A similar device is known from DE 10 2010 054 165 B3. Here,
a device for the transcutaneous stimulation of the vagus nerve of the human
body is
described which electrode head with two electrodes is arranged in the region
of the
Cymba conchae; such a positioning of the electrodes has been proven as being
beneficial. Thereby, the region of the Cymba conchae is that region of the
concha
of the ear which is located above the Crus helicis; it is also called
Hemiconcha
superior. Then, below the Crus helicis downwards the region of the Cavum
conchae extends. Finally, also DE 10 2011 018 228 Al shows a similar solution.
It has been proven as being difficult to arrange the electrode head with the
electrodes in the ear in such a manner that an optimized contact quality is
given for
the transcutaneous stimulation. A contact of the electrodes is not only
optimized
which causes no too high resistance between the electrodes; also, a too low
resistance between the electrodes is detrimental and thus not optimal.
Thus, it is an object of the present invention, to supply a device of the
mentioned
kind by which it is possible for the physician or the patient by himself in a
simple
manner to position the stimulation device in the ear in such a way that an
optimal
contact quality for the stimulation can be obtained.
The solution of this object by the invention is characterized in that the
signal means
comprise a plurality of signal elements, wherein different signal elements are
switched in dependence on pre-determined bandwidths of the resistance.
Thereby, the signal means can be firmly connected with the device; but it is
also
possible that the signal means are separable or are separated from the device
and
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that the controlling device and the signal means can communicate via a wire or
via
a wireless connection with another. In the latter case the signal means can be
separated from the device und can be better observed during the search of an
optimal position for the transcutaneous stimulation.
Furthermore, it is beneficial for a good observation of the signal means
during the
arrangement of the electrodes on the skin surface when according to a further
development the electrode carrier with the electrodes at the one hand (thus
the
otoplastic) and the controlling device at the other hand (thus the stimulator
as such)
are designed as separate parts which are in connection with another, wherein
the
signal means are firmly connected with the controlling device.
Thereby, the signal elements can be light emitting diodes, wherein the light
emitting diodes emit preferably light of different colour. Thereby, three
light
emitting diodes can be arranged. The three light emitting diodes can emit
green,
yellow and red light and serve as "traffic light" (see below). Also an
equipment
with five different coloured light emitting diodes has been proven so that it
is
possible to recognize the direction of the optimization in an easier manner.
The signal means can also comprise a signal element for displaying of a
cipher.
Hereby, a cipher between "0" and "9" can be displayed to be able to evaluate
the
contact quality.
The at least one signal element can also be, according to another embodiment,
an
acoustic sender; hereby, especially a piezoelectric crystal is considered. The
control
device can thereby be designed to control the acoustic sender in dependence on
the
resistance which exists between the electrodes to emit different frequencies.
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The at least one signal element can also be, according to another embodiment,
a
sender which emits a signal which can be sensed by the user of the device.
Hereby,
especially a sender is considered which emits vibrations. Accordingly, tactile
stimuli could then be recognized by the user of the device which deliver
information concerning the contact quality (such solutions are known as
vibration
means as used in mobile phones).
As a further alternative embodiment it is possible that said signal element is
designed as screen on which information is given as plaintext concerning the
change of the position of the electrodes on the skin.
According to the invention generally the optimization of the stimulation
quality is
concerned which should be achieved in such manner that a feedback concerning
the
contact quality is given to the user respectively patient of the device from
the
device. Thereby, according to a preferred embodiment of the invention also
hints
are given to the user how he or she if applicable should alter the position of
the
electrodes on the surface of the skin to obtain a better result.
The proposed device can thereby work due to a preferred embodiment like a
"traffic light", wherein in this case e. g. three light emitting diodes are
arranged
which signal the status of the contact quality. Thereby, three different
colours can
be provided ("green" ¨ "yellow" ¨ "red"), wherein for sake of the display of
an
intermediate status also two light emitting diodes can glow simultaneously
(namely
"green and yellow" or "yellow and red"). This delivers a hint to the user if a
re-
positioning of the electrodes on the skin surface leads to an improved or to a
deteriorated contact quality.
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When the "traffic light" at first shows "red" the user displaces the electrode
head
on the skin surface ¨ quite also by means of "trial and error" ¨ until
"yellow" is
(also) glowing. The user can then further extrapolate the done change of
position to
see if after the (complete) extinguishing of "red" then "green" is (also)
glowing. If
5 "green" is glowing the user can be sure that an optimal basis is given for
the
subsequent stimulation.
Generally, it is also possible that not only several lamps (LEDs) with
different
colours are used as signal means; also, only one light emitting diode can be
used
which can glow in different colours. Furthermore, it can be provided that the
intensity of the glowing is varied to deliver a respective signal.
The "traffic light" can also be realized in such a way that it is shown on a
(colour)
display. Alternatively, also a bar instead of a "traffic light" can be
displayed ¨ in
this case for example by using a monochrome display ¨ which is longer or
shorter
in dependence on the measured resistance.
With respect to the finding of an improved position of the electrodes on the
skin
surface inter alia the following measures can be taken from the user:
The change of the position of the pair of electrodes relatively to the skin ¨
especially in the region of the Cymba conchae ¨ can comprise a translational
movement of the electrode head; this movement can be provided generally in all
directions on the skin surface and parallel to the same. Then, the location of
the
stimulation can be changed at one location by circular swivelling of the
electrodes
respectively electrode carrier. Also, a pivoting of the plane, which is formed
by the
electrodes, can be done relatively to the plane of the skin to obtain a higher
degree
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of parallelism to the skin surface. Also, a change of the contact pressure of
the
electrodes on the skin ¨ mostly by an increase ¨ can be considered.
This can also be done in connection with other flanked measures: So, a
degreasing
of the skin surface can be carried out. On the other hand also the application
of a
contact medium in an appropriate manner can be considered (in this case a
sufficient amount of contact medium has to be chosen to obtain an improvement
of
the contact; at the other hand also too much contact medium must be avoided to
prevent a "short circuit" between the electrodes via the skin surface which
would
erode the aimed therapeutic effect).
Also, it can be provided that the electrodes are equipped with structural
means for
the increase respectively for the homogenization of the contact conditions (e.
g. a
"cover" for the electrode carrier).
Thereby, the display by means of the signal means respectively signal elements
according to the invention deliver as a result an indicator with respect to
the
electrical resistance between the electrodes of the stimulation device
(respectively
for its reciprocal, i. e. for the electrical conductivity).
Thereby, also a display of the voltage can occur ¨ which results again via the
Ohm's law to the magnitude of the resistance between the electrodes ¨ which
voltage must be applied for the creation of a defined current (i. e. of a
testing
current) between the electrodes.
So, for example a testing current of 100 A can be taken as a basis and the
voltage
can be displayed by the signal elements which is necessary for reaching said
testing
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current. Then, via the Ohm's law (U = R x I) a statement can be made
concerning
the present resistance respectively the impedance.
If a too high voltage is necessary (above a predetermined limit) the signal
means
deliver the information "no contact" ¨ "red traffic light" (i. e. too high
resistance).
However, the device would also show the "red traffic light" if the current and
thus
the resistance is too low, i. e. if a "short circuit" is given.
For the "traffic light" can then for example at the mentioned testing current
of 100
1() A a range can be defined:
- green: till 40 V
- yellow: 40 to 60 V
- red: above 60 V
As mentioned the optimal stimulation range must be limited not only upwards
(in
the direction of high voltages) but also downwards for which reference is made
to
the above explanations with respect to the "short circuit". If namely the
contact
quality is too good, possibly already prior to the contact with the ear (for
example if
too much contact gel was applied which establishes an electrical conductive
connection between the electrodes even prior the insertion in the ear), the
user of
the device should get also hints for the optimization, analogue to too high
voltage,
then however also at too low voltage.
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Thus, that means the following: The establishment of beneficial conditions for
an
efficient transcutaneous stimulation can be defined to one side clearly. For
this a
defined voltage can be declared which must be applied for reaching a testing
current. In this case the resistance lies until an allowed limit in the ranges
which is
therapeutical effective, which can be read from the required voltage for
reaching
the set current.
In the case of disadvantageous conditions for an effective transcutaneous
stimulation two cases must be distinguished.
On the one hand the resistance (corresponding to the required voltage for
reaching
of a set current) can be too high because the contact quality between the skin
and
the electrode is not sufficient.
On the other hand the resistance can also be too low; then, a short circuit
exists via
the skin surface from the stimulation to the reference electrode without that
the skin
and so the receptive areas of the nerves are flown through the current.
Accordingly, as a further development of the proposed concept it can be
provided
that the "traffic light" does not only comprise three colours ("green" ¨
"yellow" ¨
"red") by which generally only a too bad and a too good conductivity can be
shown. Additional, it can be provided that two further light emitting diodes
are
used which differentiate the traffic light constellation "red" concerning "too
high
resistance" and "too low resistance" in the above meaning. In this case the
"traffic
light" would be provided with five lights.
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In this connection the following should be mentioned: The measured resistance
values can comprise variances in dependence on the specific circumstances and
on
the individual user, so that it is sometimes difficult to determine
previously, i. e.
prior a specific application, value ranges for the resistance respectively
contact
voltage which are shown by means of display elements. Accordingly, a further
embodiment provides that the display ranges for the measures values (i. e. in
the
case of the "traffic light": green, yellow or red) are determined individually
respectively at least adapted, i. e. adjusted. The system would be in so far
adaptive
respectively it can adjust itself to specific circumstances in the meaning of
a self-
learning software. Hereby, it can thus be provided that for the operation of
the
stimulation device a software is employed which is "self-learning" and carries
out
respective adjustments automatically.
Hereby, it can be of course helpful instead of a three-element display (as in
the case
of the classical "traffic light") to realize a finer subdivision ¨ as the case
may be a
significant finer one. This can be developed till that status that a value
between "0
%" and "100 %" is displayed which allows more precise conclusions on the
contact
quality.
Because the display changes in real-time the user of the device respectively
the
physician would obtain permanently a hint if he or she is on the right way in
the
search for an optimal positioning of the electrodes.
In the drawing an embodiment of the invention is depicted. The only figure
shows
the view of a pinna (ear conch) in which a device for the application of a
transcutaneous stimulation stimulus is inserted.
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In the figure a device 1 for the transcutaneous stimulation of a section of
the human
ear 2 is depicted. The device 1 comprises a holding rod 8 which is
longitudinally
movable in a base part which also comprises a controlling device 6. At the
base
part a resting part 9 is arranged. The general positioning of the device 1 in
the ear 2
5 results from the indication of the substantial parts of the ear 2, namely
the Pinna P
with the Cavum conchae Ca, the Cymba conchae Cy, the Tragus T and the Crus
helicis Cr.
At one of the ends of the holding rod 8 an electrode carrier 5 is arranged
which
10 comprises two electrodes 2 and 4 between which a potential difference is
created
for the purpose of a transcutaneous stimulation.
Insofar the device 1 corresponds at first to pre-known solutions, wherein
especially
and explicitly reference is made to DE 10 2010 054 165 B3 of the patent
applicant
where such a device is explained in detail.
Accordingly, the device 1 is designed to be attached in the region of the
vagus
nerve at the ear 2 of the person who uses the device. Thereby, a
transcutaneous
stimulation of the vagus nerve can be carried out.
It is essential that the device 1 comprises presently signal means 7 which
display
respectively indicate the electrical resistance between the electrodes 3 and 4
when
the device is arranged at respectively in the ear 2. This signal means 7
comprise in
the embodiment three signal elements 7', 7" and 7' which are controlled in
dependence on the actual measured resistance.
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The three signal elements 7', 7", 7" ' are three light emitting diodes of
different
colours in the embodiment, namely green (7'), yellow (7") and red (7").
During movement of the electrode carrier 5 with the electrodes 3 and 4 the
measured electrical resistance is changing so that in dependence on this ¨ in
the
meaning of the above explanations ¨ one (respectively also simultaneously two)
of
the light emitting diodes are controlled. So, the user can see immediately if
good or
at least useful conditions are given for the execution of a transcutaneous
stimulation.
At "green" the contact conditions are good, the stimulation can be carried out
efficiently.
At "yellow" the contact conditions deteriorate, at "red" no useful contact
conditions
are given.
As explained above for example two further light emitting diodes (not
depicted)
can be provided to indicate that in the case of non-useful contact conditions
(thus at
"red") a too high or a too low resistance is given.
At a too high resistance relief can be obtained by means of contact gel, at
too low
resistance as the case may be a cleaning / de-greasing of the electrodes
respectively
of the electrode carrier (from contact gel) respectively of the skin surface
must be
carried out.
In this connection it can also be considered that the device sticks to the
mentioned
three light emitting diodes 7', 7" and 7" ' and the additional information
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concerning a too high respective a too low resistance is issued by an acoustic
signal. Accordingly, it can also be provided due to the proposed concept that
optical and acoustical signal elements are combined. So, by movement of the
electrode carrier 5 with the electrodes 3 and 4 across the skin surface of the
Cymba
conchae Cy an optimal position for the stimulation can be found by regarding
the
signal means 7.
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List of References:
1 Device for the transcutaneous stimulation
2 Ear
3 Electrode
4 Electrode
5 Electrode carrier
6 Controlling device
7 Signal means
7' Signal element
7, Signal element
Signal element
8 Holding rod
9 Resting part
Ca Cavum conchae
Cy Cymba conchae
T Tragus
Cr Crus helicis
Pinna
